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Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects

Healthy Subject Clinical Trial

Official title:
Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects

Clinical Trial Summary

The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study

Clinical Trial Description

XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04312568
Study type Interventional
Source Sihuan Pharmaceutical Holdings Group Ltd.
Contact
Status Completed
Phase Phase 1
Start date August 10, 2018
Completion date December 7, 2018
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